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Fat grafting vs. flap surgery: which is better for breast reconstruction after radiation?

NCT ID NCT07641985

Disease control Sponsor: Maastricht University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This study compares two methods of breast reconstruction in women who had a mastectomy and radiation for breast cancer: autologous fat transfer (AFT) and DIEP flap surgery. About 280 participants will be randomly assigned to one of the two procedures. The main goal is to see if AFT provides similar satisfaction with breast appearance and feel, while causing fewer major complications and being more cost-effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Autologous fat transfer (AFT) and Deep Inferior Epigastric Perforator (DIEP) flap procedure
What this could lead to
If successful, this could show that fat grafting is a simpler, less invasive option for breast reconstruction with fewer complications and similar satisfaction to flap surgery.
What could go wrong
This is a non-inferiority trial, so it may only show that fat grafting is not worse than flap surgery, not necessarily better. Results depend on patient satisfaction and complication rates, which vary individually.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 280 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jul 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Female, aged \>18 years. * BMI between \> 22 and \<35 kg/m2 * History of breast cancer treated with mastectomy (minimally 3 months after mastec-tomy) and post mastectomy chest wall radiotherapy (completed ≥6 months before en-rollment). * May include contralateral/bilateral prophylactic mastectomy if at least one side had cancer and radiation. * Desires autologous breast reconstruction and accepts randomization between AFT and DIEP. * Medically fit for surgery (ASA I-III). * Sufficient donor tissue for both AFT (enough fat) and DIEP (suitable abdominal tissue and vasculature). * No evidence of active cancer at enrollment; remission confirmed. * Able to wear the EVE device (if randomized in AFT). * Capable of understanding study information and questionnaires (Dutch or English), willing to give informed consent, and able to comply with follow-up. Exclusion Criteria: * Prior autologous breast reconstruction on the intended side. BMI \<22 or \>35 kg/m2 * Contraindication to DIEP flap (e.g., prior abdominoplasty or abdominal scars affecting perforators). * Contraindication to AFT (e.g., insufficient fat or conditions impairing fat graft viability). * Current chemotherapy or completed less than 4 weeks prior to enrollment. * Serious uncontrolled comorbidities making elective surgery unsafe (e.g., unstable heart disease, severe coagulopathy, end-stage organ failure). * Active smoker or not abstinent for at least 6 weeks pre-operatively. * Pregnant at time of enrollment. * In case low compliance is expected or an inability to comply with study protocol, including unwillingness to undergo either AFT or DIEP, or inability to complete follow-up (due to language, cognitive issues, or relocation plans). * Previous enrollment in this trial (patients can only be included once, even if later presenting for contralateral reconstruction). * Allergy to lidocaine or silicone

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Breast cancer radiation Breast reconstruction Breast reconstruction after mastectomy Lipofilling

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AzM

    RECRUITING

    Maastricht, Limburg, 6229, Netherlands

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